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A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 2024 to Sep 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Nov 2024 to Sep 2025 · Site details revised at 5 of 5 sitesv6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Nov 2024 to Sep 2025
    • Site details revised at 5 of 5 sites
  2. Study sites: 2 to 5v5
  3. Site contacts updated at 1 of 2 sitesv4
  4. Study sites: 1 to 2 Primary completion date: Apr 2024 to Oct 2024 · Completion date: Jun 2024 to Nov 2024 · Study arms: 2 to 3 · 3 morev3 Show 6 more changesShow less
    • Primary completion date: Apr 2024 to Oct 2024
    • Completion date: Jun 2024 to Nov 2024
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 5 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date changed from estimate of Feb 2023 to Jan 30, 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
Trial Details
NCT Number NCT05733546
Lead Sponsor COMPASS Pathways
Conditions Major Depressive Disorder
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov